Medicines and Healthcare products Regulatory Agency

MANUFACTURER'S AUTHORISATION
1: Authorisation Number UK MIA(IMP) 42551
2: Name of authorisation holder COPEA PHARMA LIMITED
3: Address(es) of manufacturing site(s)

COPEA PHARMA LIMITED, 25 COMPASS WEST, SPINDUS ROAD, LIVERPOOL, L24 1YA, UNITED KINGDOM

4: Legally registered address of authorisation holder COPEA PHARMA LIMITED, 25 COMPASS WEST, SPINDUS ROAD, LIVERPOOL, L24 1YA, UNITED KINGDOM
5: Scope of authorisation and dosage forms ANNEX 1 and/ or ANNEX 2
6: Legal Basis of authorisation
7: Name of responsible officer of the competent authority of the member state granting the manufacturing authorisation Confidential
8: Authorisation Date 29/07/2022
9: Annexes attached Annex 1 and/or Annex 2
SCOPE OF AUTHORISATION
Annex 2
Name and address of the site:

COPEA PHARMA LIMITED, 25 COMPASS WEST, SPINDUS ROAD, LIVERPOOL, L24 1YA, UNITED KINGDOM

Human Investigational Medicinal Products
Authorised Operations
Authorised Operations
MANUFACTURING OPERATIONS (according to part 1)
IMPORTATION OF MEDICINAL PRODUCTS (according to part 2)
Operations
Part 1 - MANUFACTURING OPERATIONS
[ 1.1 ] Sterile Investigational Medicinal Products
    [ 1.1.3 ] Batch certification
[ 1.2 ] Non-sterile investigational medicinal products
    [ 1.2.1 ] Non-Sterile Products (processing operations for the following dosage forms)
        [ 1.2.1.5 ] Liquids for external use
        [ 1.2.1.6 ] Liquids for internal use
        [ 1.2.1.8 ] Other solid dosage forms
        [ 1.2.1.11 ] Semi-solids
    [ 1.2.2 ] Batch certification
[ 1.3 ] Biological investigational medicinal products
    [ 1.3.2 ] Batch certification
        [ 1.3.2.2 ] Immunological products
        [ 1.3.2.5 ] Biotechnology products
[ 1.4 ] Other investigational medicinal products or manufacturing activitiy
    [ 1.4.1 ] Manufacture of:
        [ 1.4.1.1 ] Herbal products
[ 1.5 ] Packaging
    [ 1.5.1 ] Primary packaging
        [ 1.5.1.1 ] Capsules, hard shell
        [ 1.5.1.2 ] Capsules, soft shell
        [ 1.5.1.5 ] Liquids for external use
        [ 1.5.1.6 ] Liquids for internal use
        [ 1.5.1.8 ] Other solid dosage forms
        [ 1.5.1.11 ] Semi-solids
        [ 1.5.1.12 ] Suppositories
        [ 1.5.1.13 ] Tablets
        [ 1.5.1.15 ] Other non-sterile medicinal products
            Powders, Granules
    [ 1.5.2 ] Secondary packaging
Part 2 - IMPORTATION OF MEDICINAL PRODUCTS
[ 2.2 ] Batch certification of imported medicinal products
    [ 2.2.1 ] Sterile Products
        [ 2.2.1.1 ] Aseptically prepared
        [ 2.2.1.2 ] Terminally sterilised
    [ 2.2.2 ] Non-sterile products
    [ 2.2.3 ] Biological medicinal products
        [ 2.2.3.2 ] Immunological products
        [ 2.2.3.5 ] Biotechnology products
[ 2.3 ] Other Importation Activities
    [ 2.3.1 ] Site of Physical Importation
    [ 2.3.2 ] Importation of Intermediate which undergoes further processing
    [ 2.3.4 ] Other
        Importation of QP Certified IMPs from a country on the approved country for import list